Direction Number: - NECSAT 2014/003

Patient Group Direction (PGD) for the Administration of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) by Registered Professionals to Individuals Accessing NHS Services in Durham, Darlington, Tees (DDT) and Cumbria, Northumberland, Tyne & Wear (CNTW) YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT. Direction Number: - NECSAT 2014/003 Valid from: 1 st March 2014 Review date: 1 st March 2016 Expiry date: 31 st May 2016 This patient group direction has been developed & produced by: - Title Name Signature Date Medicines Optimisation Pharmacist (North of England Commissioning Support) Medicines Optimisation Pharmacist (North of England Commissioning Support) Consultant Public Health Medicine (Public Health England, DDT) Immunisation and Screening Manager (Public Health England, DDT) Immunisation and Screening Coordinator (Public Health England, CNTW) Marie Thompkins (Senior Pharmacist) Hira Singh (Senior Pharmacist) Dr Malathi Natarajan (Senior Doctor) Sandra Ansah (Senior Nurse) Jane Morphet (Senior Nurse) 26/02/2014 26/02/14 27/02/14 27/02/14 28/02/14 This PGD has been approved for use in Durham, Darlington and Tees by: - Title Name Signature Date Assistant Medical Director (DDT Team, NHS England) Dr James Gossow (Governance Authorisation) 28/02/14 This PGD has been approved for use in Cumbria, Northumberland, Tyne & Wear by: - Title Name Signature Date Medical Director (CNTW Area Team, NHS England) Dr Mike Prentice (Governance Authorisation) 06/03/14 PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 1 of 11

1. Clinical Condition or Situation to Which the Direction Applies Indication (defines situation or condition) For active immunisation against measles, mumps and rubella in children aged over 12 months and adults as part of the national immunisation programme Objectives of care To prevent infectious disease and promote health. To reduce morbidity & mortality and to eradicate disease. Inclusion criteria (as per Public Health England (PHE) Green Book Guidance (Jan 2014)) Only use those criteria that are specific to your authorised role & competence. Ensure appropriate consent has been obtained before commencing any vaccination. All children and unimmunised adults requiring vaccination including; sero-negative women of childbearing age, health care workers and all travellers to epidemic or endemic areas falling into one of the following categories: - As a primary (1 ) course in previously un-immunised children or where there is an unreliable or no history of previous immunisation against measles, mumps & rubella. To complete a primary immunisation course of vaccination against measles, mumps & rubella Susceptible women of child bearing age who have not previously been immunised or who have tested seronegative to rubella Health care workers who may put pregnant women at risk of infection As an alternative vaccine or as a reinforcing dose when recommended by the DH or Public Health England As advised by Public Health advisors during local outbreaks Unimmunised adults requiring vaccination (See Green Book updated chapter 28 for full details and additional information) Exclusion criteria (Refer to current SPC and PHE Green Book Guidance for additional details) General Exclusions Children under 12 months of age. No valid consent (if applicable). Pregnancy. Immunosuppressed individuals. History of hypersensitivity to any measles, mumps or rubella vaccine, or to any excipients; Patient is acutely unwell (postpone vaccination until recovered. Minor infections without fever or systemic upset are not reasons to postpone immunisation). Confirmed anaphylaxis to any component of the vaccine. Severe hypersensitivity to any ingredient or component of the vaccine(s) including neomycin. (please also refer to precautions section). Current neurological deterioration, including poorly controlled epilepsy defer until condition has stabilised Specific exclusions (in addition to those listed above under general exclusions) For MMRVAXPRO only: Active untreated tuberculosis Blood dyscrasias, leukaemia or other malignant neoplasms PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 2 of 11

Precautions Pregnancy (known or suspected) There is no evidence rubella containing vaccines are teratogenic. However as a precaution, MMR vaccine should not be given to women known to be pregnant. If MMR is given to adult women they should be advised to guard against pregnancy for one month. All children with egg allergy should receive the MMR vaccination as a routine procedure in primary care (please refer to Green Book for further details). Hypersensitivity reactions to previous dose of vaccine or component of vaccine: - NB. "Local adverse reactions that generally start within a few hours of the injection and are usually mild and self - limiting. Although these are often referred to as hypersensitivity reactions, they are not allergic in o rigin, but may be either due to high titres of antibody or a direct effect of the vaccine product, e.g. endotoxin in whole -cell bacterial vaccines. The occurrence or severity of such local reactions does not contraindicate further doses of immunisation with the same vaccine or vaccines containing the same antigens Action if excluded Discuss with or refer to clinician/doctor. Ensure all actions/decisions are documented. The risk to the individual of not being immunised must be taken into account. If postponement due to acute illness, arrange a future date for immunisation. Circumstances in which further advice should be sought from a doctor and / or specialist Children who have had documented anaphylaxis to the vaccine itself should be assessed by an allergist. NB: children with egg allergy should receive the MMR vaccination as a routine procedure in primary care and do not require referral In individuals on immunosuppressive treatment or with immunodeficiency. Idiopathic thrombocytopaenic purpura occurring within 6 weeks of the first dose seek advice from HPA regarding serum testing before a second dose is administered Please refer to current SPC special warnings & special precautions for use section for full details & relevant current chapters of the Green Book. Special Considerations / Additional Information Contraception for 1 month post vaccination must be advised due to risk to foetus When MMR is given within three months of receiving blood products, such as immunoglobulin, the response to the measles component may be reduced. This is because such blood products may contain significant levels of measles - specific antibody, which could then prevent vaccine virus replication. Where possible, MMR should be deferred until three months after receipt of such products. If immediate measles protection is required in someone who has recently received a blood product, MMR vaccine should still be given. To confer longer-term protection, MMR should be repeated after three months.) Breast feeding is not a contraindication to MMR immunisation and MMR vaccine can be given to breast-feeding mothers without any risk to their baby. Four weeks should be left between giving MMR vaccine and carrying out Tuberculin testing PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 3 of 11

Action if patient declines treatment Ensure patient/guardian/carer fully understands the risks of declining vaccination. Advise about protective effects of vaccine & the risks of infection and disease complications. Document refusal, advice given, actions/decisions in notes (written or electronic). Inform or refer to doctor as appropriate. 2. Description of Treatment. Name, strength & formulation of drug MMR Measles, Mumps and Rubella live attenuated Vaccines Priorix (GlaxoSmithKline), - Powder and solvent for solution for injection - Before reconstitution the powder is white to slightly pink and the solvent is a clear, colourless liquid - 0.5ml dose after reconstitution MMRVaxPRO (Sanofi Pasteur MSD) - Powder and solvent for suspension for injection in a pre-filled syringe - Before reconstitution the powder is a light yellow compact crystalline cake & the solvent is a clear colourless fluid - 0.5ml dose after reconstitution Legal Status: POM Prescription Only Medicines Dosage/Dose range: 0.5ml (1 single dose) Route/Method: Intramuscular injection (IM) is the preferred route: - Anterolateral aspect of thigh in infants; deltoid region in older children, adolescents and adults. Not to be given intravenously. Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder, e.g. thrombocytopenia.) PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 4 of 11

Frequency of Administration: (Refer to PHE Green Book Guidance for additional details) Two (2) doses Administered at 12-13months and 3years 4 months Interrupted primary courses: - Should be resumed but not repeated. PRIMARY IMMUNISATION COURSE: - Children administered 1 st dose before 1 st birthday:- Ignore and administer primary immunisation course following national recommendations ensuring a 3month interval is left between doses Children with unknown or incomplete immunisation status:- For individuals <18months of age a minimum interval of 3months should be left between first and second doses For individuals >18months of age a minimum of 1month should be left between first and second doses SERO-NEGATIVE WOMEN OF CHILDBEARING AGE Two (2) doses or evidence of sero-conversion to the relevant antigen LOCAL OUTBREAKS One (1) or Two (2) doses according to advice from Public Health Advisors Please refer to the NHS England Green Book (2013), Chapter 24 for full details. See Appendix 1 Maximum dose / Maximum number of vaccinations: Maximum dose: 0.5ml Maximum no. of vaccinations: Two Follow up treatment: As per current DH and PHE Immunisation Schedule (see Appendix 1) PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 5 of 11

3. Further Aspects of Treatment: Relevant Warnings & Potential Adverse Effects Relevant Warnings: - See Manufacturers SPC for full details / current Green Book Chapter 21,23 & 28 Potential Adverse Effects/ Reactions: - Very Common & Common reactions Uncommon, rare and very rare Injection site tenderness/pain, erythema & oedema. Irritability, increased crying, fever (>38 C). (Local reactions within 48hrs after vaccination and persisting for 1-2 days). Decreased appetite, diarrhoea and vomiting. Decreased activity; Upper respiratory tract infections. Rash ( commonly up to 1 week after vaccination and persisting for 2-3 days) Febrile convulsions, with or without fever (If occur then seek doctor/medical advice); High fever (> 40.5 C), Abnormal crying; Anaphylactic reaction; Arthropathy. Parotid gland enlargement (occurs up to three weeks after vaccination and more likely with 1st dose) See Manufacturers SPC for full details of all potential adverse reactions. Identification and Management of Adverse Reactions See anaphylaxis guidelines Patient/ Carer / Guardian requested to report side effects Advice on management: - Chapter 8 of the Green Book provides detailed advice on managing ADRs following immunisation, e.g. Analgesia for pain &/or fever; prevention of dehydration; drinking plenty of clear fluids). Refer to doctor/specialist if appropriate Please refer to current SPC special warnings & special precautions for use section for full details & relevant current chapters of the Green Book. Reporting Procedure of Adverse Effects Report to doctor if appropriate & document in patient s medical records. All suspected Adverse drug reactions to vaccines labelled with a black triangle ( ), should be reported to the MHRA using the yellow card scheme. For established vaccines only report serious adverse reaction. Please refer to www.mhra.gov.uk/yellowcard and Green Book- Chapter 9 See manufacturers Summary of Product Characteristics for details of all potential adverse reactions. Advice to Patient / Carer (verbal or written) Contraception required for 1month post vaccination to avoid risk to foetus Explain protection level expected from vaccine. Provide a patient information leaflet and discuss as required. Provide advice on & explain potential warnings & side effects and request to report them if they occur. Provide advice on management of adverse reactions (see above and manufacturers SPC). Explain procedure for dealing with anaphylaxis /severe allergic reactions. Explain the Out of Hours procedure. Give date of next vaccine if applicable. Complete patient-held vaccination record Provide patient with vaccination record card (to include date of next vaccination, completion of course or blood test) if applicable. PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 6 of 11

Arrangements for Referral to Medical Advice Doctor / specialist appointment as and when appropriate Records In all cases manual records including the Personal Held Child Record, computerised records and data collection for Child Health Information Services (CHIS) should include: - Patient s name and date of birth; Reason vaccination required; Dose, site and route of injection; Date of administration; Brand name, batch number & expiry date of vaccine; Whom administered by & signature of vaccinator (if not recorded on computer). Confirmation that there are no contraindications; That side effects have been discussed; Support literature given (if applicable); Confirmation that consent has been obtained; Signature and printed name and designation (in black ink) for paper records. For computer records, ensure data authentication of practitioner delivering care. Additional Facilities Access to a current BNF and online Green Book information Store in a refrigerator (+2 C to +8 C). Have access to a telephone. Stock control & storage of vaccines in accordance with national and local policies / protocols/ guidelines. Emergency equipment available including immediate access to Epinephrine (Adrenaline) 1in 1000 injection (as a minimum). (Please refer to PGD for adrenaline as applicable) Please be aware of Resuscitation Council Guidelines References NHS Executive HSC 2000/026 (9 th August 2000): Patient Group Directions [England only]. Public Health England, Immunisation Against Infectious Disease (The Green Book): Chapter 21 (Measles) Chapter 23 (Mumps), Chapter 28 (Rubella), Accessed at https://www.gov.uk/government/collections/immunisation-against-infectiousdisease-the-green-book on 06/01/2014. British National Formulary (BNF), online edition Jan 2014. Nursing and Midwifery Council (NMC), 2007: Standards for Medicines Management. Nursing and Midwifery Council (NMC), 2007: Record Keeping Advice Sheet. Nursing and Midwifery Council (NMC), 2008: Code of Professional Conduct: standards of conduct, performance & ethics for nurses and midwives. Resuscitation Council (UK), October 2010: Emergency Medical Treatment of anaphylactic reaction by first medical responders and community nurses. www.resus.org.uk/siteindx.htm Sanofi Pasteur MSD Limited, MMRVAXPROl - Summary of Product Characteristics (SPC), (accessed from Electronic Medicines Compendium on 17/01/2014). GlaxoSmithKline UK, Priorix - Summary of Product Characteristics (SPC), (accessed from Electronic Medicines Compendium on 17/01/2014). NHS England Service Specification No.10: Measles, Mumps and Rubella Immunisation Programme (Nov.13). PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 7 of 11

4. Characteristics of Healthcare Professional Staff Only those healthcare professionals that have been specifically authorised by their clinical lead/supervisor/manager may use this PGD for the indications defined within it. Under current legislation, only the following currently registered healthcare professionals may work under Patient Group Directions (PGDs). These professionals may only supply or administer medicines under a PGD as named individuals. These professionals include - Pharmacists Nurses Chiropodists/Podiatrists Health Visitors Physiotherapists Midwives Dieticians Optometrists Registered Orthoptists Prosthetists and Orthotists Radiographers Occupational Therapists Speech and Language Therapists Dental Hygienists Dental Therapists State registered paramedics or individuals who hold a certificate of proficiency in ambulance paramedic skills issued by the Secretary of State, or issued with his approval. Qualifications required (professional registration applies to specific professions) Professionals using this PGD must be currently registered with their relevant professional body, e.g. For Nurses: - Nursing & Midwifery Council (NMC) For Pharmacists: - General Pharmaceutical Council (GPhC) For Allied Health Professionals: - Health Professions Council Additional requirements (applies to all staff) Maintain knowledge of vaccinations; either through a recognised course or through in-house training supported by attendance at vaccination study day(s). Meet the HPA National minimum standards in immunisation training 2005 either through training or professional competence ensuring that annual training is offered to all staff Have up to date resuscitation skills and anaphylaxis training (and competent to recognise & manage anaphylaxis). Competent to undertake immunisations and have a current authorised Adrenaline PGD. Will have undertaken training in the role, care and administration of the medicine specified in the PGD. Have access to a current BNF and Immunisation against infectious disease (Green Book). Any additional training requirements as deemed necessary by your organisation or authorising body. Continued training requirements (applies to all staff) Annual attendance at an accredited update on resuscitation skills and the management of anaphylaxis within the community/primary care (mandatory). Maintenance of own level of updating and competence with evidence of continued professional development. Annual updates in immunisation (recommended). Any continued training requirements as deemed necessary by your organisation or the authorising body. PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 8 of 11

Management & Monitoring of Patient Group Direction NECSAT 2014/003 MMR vaccine (Measles, Mumps, Rubella) Individual Healthcare Professional Authorisation This form is to be used for the purpose of managing, monitoring and authorising the use of this Patient Group Direction by the named healthcare professional. This page is to be retained by the individual healthcare professional/practitioner. This PGD is to be read, agreed to and signed by all registered Healthcare Professionals it applies to. Healthcare Professionals must be authorised by the person(s) named below before using the PGD. By signing this document, the healthcare professional confirms that they understand the PGD, that they are competent to work under this PGD, that they will practice in accordance with the parameters of the PGD and accept full clinical responsibility for any decisions made with using this PGD). Patient Group Directions should be used in conjunction with reference to national or local policies, guidelines or standard text (e.g. manufacturers Summary of Product Characteristics) and DO NOT replace the need to refer to such sources. Name of Healthcare Professional:- is authorised to administer MMR VACCINE ( MMRVAXPRO, Priorix ) under this Patient Group Direction (NECSAT 2014/003) Signature of Healthcare Professional: - Date signed: - State profession: - Authorisation to use this PGD by: - This above named healthcare professional has been authorised to work under this PGD by: Name of Manager/Clinical Lead: - Signature of Manager/Clinical Lead: - Date signed: - PGD Valid from: 1 st Mar. 2014 Review Date: - March 2016 Expiry Date: - 31 st May 2016 PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 9 of 11

Management & Monitoring of Patient Group Direction NECSAT 2014/003 MMR vaccine (Measles, Mumps, Rubella) Healthcare Professional Authorisation (service/practice list) This form is to be used for the purpose of managing, monitoring and authorising the use of this Patient Group Direction by the named healthcare professionals. This page should be signed by all healthcare professionals authorised to use this PGD and retained and kept on file by the service/practice manager as a record of all practitioners authorised to use this PGD The following healthcare professionals are authorised to administer MMR (MMRVAXPRO, Priorix ) vaccine under the Patient Group Direction (NECSAT 2014/003) PGD Valid from date: 1st March 2014 PGD Expiry Date: 31 st May, 2016 Healthcare Professional Authorised by: Name Signature Date Name Signature Date PGD Valid from: 1 st Mar. 2014 Review Date: - March 2016 Expiry Date: - 31 st May 2016 PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 10 of 11

Appendix 1 The complete routine immunisation schedule 2013/14 PGD for MMR (Measles, Mumps and Rubella) Vaccine (NECSAT 2014/003). Review Mar.16/ Exp.31/05/16) Page 11 of 11